BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RINGLOC-X E1 H/W 56/32MM

    MDR report key: 21825224 · Received April 11, 2025

    Report

    Report Number
    3002806535-2025-00159
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 6, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS IS A COMBINED INITIAL AND FINAL REPORT. D4: THIS DEVICE IS SOLD OUTSIDE THE US AND THEREFORE NO GUDID INFORMATION EXISTS. THIS DEVICE IS CONSIDERED SIMILAR TO (B)(4). D10: UNKNOWN BIOLOX DELTA 32MM -4MM HEAD; ITEM NUMBER: UNKNOWN; LOT: UNKNOWN. G2: FOREIGN: AUSTRALIA. G4: THE REPORTED PRODUCT IS NOT SOLD IN THE US, THE PRE-MARKET SUBMISSION NUMBER FOR THE SIMILAR PRODUCT SOLD IN THE US IS K150522. A VISUAL EXAMINATION OF THE PROVIDED PICTURES IDENTIFIED THE EXPLANTED DEVICES BUT COULD NOT BE USED TO CONFIRM THE COMPLAINT. DEVICES NOT RETURNED; FURTHER ANALYSIS CANNOT BE MADE. A REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: AP VIEW OF THE BILATERAL HIPS DEMONSTRATE BILATERAL TOTAL HIP ARTHROPLASTIES. NO ACUTE FRACTURE. NO RADIOLUCENCY. NO DISLOCATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT HIP REPLACEMENT ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATIONS. PREVIOUS DISLOCATIONS WERE REDUCED WITHOUT OPENING THE PATIENT. ATTEMPTS HAVE BEEN MADE AND ALL ADDITIONAL INFORMATION RECEIVED HAS BEEN INCLUDED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340685 RINGLOC-X E1 H/W 56/32MM HIP PROSTHESIS LPH BIOMET UK LTD. 3275979

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| R SEE H11 NARRATIVE.